Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Nolpaza control (Nolpaza 20 mg)
20 mg, enteric-coated tablets
Pantoprazole
Nolpaza control and Nolpaza 20 mg are different brand names for the same medicine.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, so that you may read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 14 days, or if your condition worsens, contact your doctor.
Do not take Nolpaza control for longer than 4 weeks without consulting your doctor.

Table of contents of the leaflet:

What Nolpaza control is and what it is used for
Important information before taking Nolpaza control
How to take Nolpaza control
Possible side effects
How to store Nolpaza control
Contents of the pack and other information

1. What Nolpaza control is and what it is used for

The active substance in Nolpaza control is pantoprazole, which blocks the enzyme responsible for producing gastric acid. In this way, the medicine reduces the amount of acid in the stomach.
Nolpaza control is used for short-term treatment of symptoms of gastroesophageal reflux disease (GERD) (such as heartburn, acid regurgitation) in adults.
Reflux refers to the backflow of acid from the stomach into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include: a painful burning sensation in the chest rising up to the throat (heartburn), a sour taste in the mouth (acid regurgitation).
Nolpaza control may relieve symptoms associated with gastroesophageal reflux disease (such as heartburn, acid regurgitation) as early as on the first day of treatment, but it is not intended for immediate symptom relief.
For complete relief of symptoms, it may be necessary to take the tablets for 2–3 consecutive days.
If there is no improvement after 14 days, or if your condition worsens, consult your doctor.

2. Important information before using Nolpaza control

When not to use Nolpaza control

If the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
If the patient is taking HIV protease inhibitors such as atazanavir, nelfinavir (used in the treatment of HIV infection). See "Nolpaza control and other medicines".

Warnings and precautions
Before starting treatment with Nolpaza control, consult a doctor if the patient:

is being treated for heartburn or indigestion continuously for 4 or more weeks;
is over 55 years old and takes over-the-counter medicines for indigestion daily;
is over 55 years old and has noticed new or changing symptoms of reflux disease;
has a history of peptic ulcer disease or has undergone stomach surgery;
has liver problems or jaundice (yellowing of the skin and eyes);
is under ongoing medical supervision due to other serious conditions or diseases;
is scheduled for an endoscopic examination or urease test;
has previously experienced a skin reaction when taking a medicine similar to Nolpaza control that reduces gastric acid secretion;
is scheduled for a specific blood test (chromogranin A level);
is taking HIV protease inhibitors such as atazanavir or nelfinavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should ask the doctor for detailed advice.

Do not take this medicine for longer than 4 weeks without consulting a doctor. If symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, consult a doctor, who will decide whether long-term treatment is necessary.
Long-term use of Nolpaza control may be associated with additional risks, such as:

reduced absorption of vitamin B12 and vitamin B12 deficiency in case of low vitamin B12 levels in the body;
hip, wrist or spine fractures, especially if the patient already has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (e.g. if the patient is taking steroid medicines);
decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to decreased potassium and calcium levels in the blood. If the medicine is used for longer than 4 weeks, consult a doctor. The doctor may order regular blood tests to monitor magnesium levels.

Immediately inform the doctor before or after using this medicine if the patient notices the appearance of the following symptoms, which may indicate other, more serious diseases:

unintentional weight loss (not related to diet or exercise);
vomiting, especially recurrent;
vomiting blood, which may look like dark coffee grounds;
blood in stool, black or tarry stools;
difficulty swallowing or pain during swallowing;
paleness and weakness (anaemia);
chest pain;
abdominal pain;
severe and/or persistent diarrhoea (because use of Nolpaza control is associated with a slightly increased risk of infectious diarrhoea);
if the patient develops a skin rash, especially in areas exposed to sunlight, the patient should inform the doctor as soon as possible, as discontinuation of Nolpaza control may be necessary. The patient should also report any other adverse reactions such as joint pain.
The doctor may decide that additional tests are necessary.
If the patient is scheduled for a blood test, they should inform the doctor about taking this medicine.
The patient may notice improvement in reflux and heartburn symptoms as early as one day after starting Nolpaza control. However, this is not a medicine intended for immediate symptom relief.
Nolpaza control should not be used preventively.
If the patient has been suffering from recurrent heartburn or indigestion symptoms for some time, they should remain under regular medical supervision.

Children and adolescents
Nolpaza control should not be used in children and adolescents under 18 years of age due to lack of safety data in this age group.

Nolpaza control and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Nolpaza control may reduce the effectiveness of other medicines. Inform the doctor or pharmacist about all medicines being taken, especially those containing any of the following active substances:

HIV protease inhibitors such as atazanavir, nelfinavir (used in the treatment of HIV infection). Nolpaza control must not be used concomitantly with HIV protease inhibitors. See "When not to use Nolpaza control";
ketoconazole (used for fungal infections);
warfarin and phenprocoumon (affect blood clotting and prevent thrombosis). Additional blood testing may be required;
methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer diseases). When methotrexate is used, the doctor may temporarily discontinue Nolpaza control, as pantoprazole may increase methotrexate blood levels.

Do not take Nolpaza control together with medicines that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole or rabeprazole) or H2 antagonists (e.g. ranitidine, famotidine).
Nolpaza control may be used if necessary together with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).

Pregnancy and breastfeeding
Do not use Nolpaza control if the patient is pregnant or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.

Nolpaza control contains sorbitol and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Nolpaza control

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is 1 tablet per day. The daily dose should not exceed 20 mg. The medicine should be taken for at least 2–3 consecutive days. Treatment with Nolpaza control should be discontinued after symptoms have completely resolved. Relief of reflux and heartburn symptoms may occur as early as one day after starting Nolpaza control; however, bear in mind that this medicine is not intended for immediate symptom relief.
Consult a doctor if symptoms do not improve after taking this medicine for a full 2 weeks.
Do not take Nolpaza control for longer than 4 weeks without consulting a doctor.
Tablets should be taken before a meal, at the same time each day. Swallow tablets whole, without chewing or dividing them, with plenty of water.

Taking more Nolpaza control than recommended
Immediately inform a doctor or pharmacist if an overdose has been taken. If possible, bring the medicine and package leaflet with you.

Missed dose of Nolpaza control
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time on the following day.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should inform your doctor immediately or contact the nearest hospital emergency department if any of the following serious adverse reactions occur.
You should also stop taking this medicine and bring the leaflet and (or) tablets with you.

Severe allergic reactions (rare (may occur in 1 out of 1,000 treated patients)): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue and (or) throat, which may cause difficulty in swallowing or breathing, urticaria, severe dizziness with rapid heartbeat and profuse sweating.
Severe skin reactions (frequency unknown (frequency cannot be estimated from available data)): the patient may notice one or more of the following symptoms – rash with swelling, blisters or skin peeling, sheet-like peeling of the skin, bleeding from the eyes, nose, mouth or genital area, and rapid deterioration in general condition. Rash after exposure to sunlight. Joint pain or flu-like symptoms, fever, swelling of glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
Other severe reactions (frequency unknown): yellowing of the skin and whites of the eyes (due to severe liver damage), kidney problems manifested by painful urination, pain in the lower back accompanied by fever.

Other adverse reactions include:

Common (may occur in 1 out of 10 treated patients): benign gastric polyps
Uncommon (may occur in 1 out of 100 treated patients): headache, dizziness, diarrhoea, nausea, vomiting, bloating and flatulence, constipation, dry mouth; abdominal pain and discomfort, skin rash or urticaria, itching of the skin, weakness, fatigue or malaise, sleep disturbances; increased liver enzyme activity in blood tests, fracture of the hip, wrist or spine.
Rare (may occur in 1 out of 1,000 treated patients): disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; joint pain; muscle pain; changes in body weight; elevated body temperature; swelling of limbs; depression; increased levels of bilirubin and lipids in the blood (detected in blood tests); breast enlargement in males; high fever and sudden decrease in circulating granulocytes – white blood cells (detected in blood tests).
Very rare (may occur in less than 1 out of 10,000 treated patients): disturbances in orientation, decreased platelet count, which may lead to increased tendency to bleed and development of skin petechiae (bruises); decreased white blood cell count, which may predispose to more frequent infections, concurrent abnormal decrease in red blood cells, white blood cells and platelets (detected in blood tests).
Frequency unknown (frequency cannot be estimated from available data): hallucinations; confusion (particularly in patients who have previously experienced such symptoms), decreased concentration of sodium, magnesium, calcium or potassium in the blood (see section 2), sensations of tingling, pricking, numbness, burning or stinging, inflammation of the large intestine causing persistent watery diarrhoea, rash possibly accompanied by joint pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Nolpaza control

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Nolpaza control contains

The active substance is pantoprazole. One enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole hemihydrate).
The other ingredients are: in the tablet core: mannitol, crospovidone (type A), crospovidone (type B), sodium carbonate, sorbitol (E 420), calcium stearate, and in the tablet coating: hypromellose, povidone K 25, titanium dioxide (E 171), iron oxide yellow (E 172), propylene glycol, macrogol 6000, talc, methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion containing sodium lauryl sulfate and polysorbate 80. See section 2 "Nolpaza control contains sorbitol and sodium".

What Nolpaza control looks like and contents of the pack
Light brownish-yellow, oval, biconvex enteric-coated tablets.
Packaging: 15 enteric-coated tablets in a blister pack, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Romania, country of export:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Manufacturer:
Krka d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
TAD Pharma GmbH
Heinz-Lohmann Str. 5
Cuxhaven
D-27472 Germany
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35/37
02-234 Warsaw 87-100 Toruń
Marketing authorisation numbers in Romania, country of export: 10738/2018/03
10738/2018/05
10738/2018/07
Parallel import authorisation number: 123/23
The following lifestyle recommendations and dietary changes may also help relieve heartburn or other symptoms related to gastric acid.

Avoid large meals.
Eat slowly.
Stop smoking.
Limit alcohol and caffeine intake.
Reduce body weight (in case of overweight).
Avoid tight clothing or belts.
Avoid eating meals less than three hours before going to bed.
Sleep with the head elevated (in case of nocturnal symptoms).
Limit consumption of foods that usually trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, spicy and acidic foods, citrus fruits and fruit juices, tomatoes.